Phase 3
N=418
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Bottom Line
View on ClinicalTrials.gov: NCT03328897 ↗Enrolled (actual)
418
Serious AEs
3.1%
Results posted
Nov 2020
Primary outcome: Primary: Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment — -10.11; -9.66; -5.87 Score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omalizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of the Itch Severity Score (ISS7) Score After 12 Weeks of Treatment |
-10.11; -9.66; -5.87 | <0.001 sig |
| SECONDARY Change From Baseline of Urticaria Activity Score (UAS7) After 12 Weeks of Treatment |
-21.82; -20.74; -11.62 | <0.001 sig |
| SECONDARY Change From Baseline of Number of Hives Score (NHS7) After 12 Weeks of Treatment |
-11.68; -11.11; -5.76 | <0.001 sig |
| SECONDARY Percentage of Patients With UAS7≤6 at Week 12 |
81; 79; 9 | <0.001 sig |
| SECONDARY Percentage of Complete Responders (UAS7 = 0) at Week 12 |
62; 39; 4 | <0.001 sig |
| SECONDARY Percentage of Patients With ISS7 Minimally Important Difference (MID) at Week 12 |
125; 125; 49 | <0.001 sig |
| SECONDARY Change From Baseline of Dermatology Life Quality Index (DLQI) Score After 12 Weeks of Treatment |
-10.4; -9.9; -6.5 | <0.001 sig |
| SECONDARY Time to ISS7 MID Response by Week 12 |
114; 109; 42; 18; 25; 10 | <0.001 sig |
Summary
The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
Eligibility Criteria
Main Inclusion Criteria:
- Symptomatic CSU patients with CSU diagnosis for at least 6 months.
- Patients must have been on an approved dose of an H1AH for CSU for at least the 3 consecutive days immediately prior to the Day -14 screening visit
- Patients must have documented current use on the day of the initial screening visit
Main Exclusion Criteria
- Clearly defined underlying etiology for chronic urticarias other than CSU (main manifestation being physical urticaria)
- Other skin disease associated with itch Urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, leukemia, or generalized cancer
Data sourced from ClinicalTrials.gov (NCT03328897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.